The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Not Applicable

Completed

• Conditions: Hyperparathyroidism
• Interventions: Drug: Lisinopril

• Registration Number: NCT01691781
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Detailed Description

The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.

Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:

1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?

2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?

The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-25
• Study Start: 2012-10
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Results First Submitted: 2017-06-19
• Results First Submitted QC: 2017-07-13
• Status Verified: 2017-08
• Results First Posted: 2017-08-10
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
• normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
• Age >18 years and <80 years
• Estimated GFR > 60ml/min

Exclusion Criteria

• Chronic Kidney Disease or eGFR<60
• Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
• Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
• History of liver failure
• History of heart failure
• The use of typical or atypical antipsychotic medications or lithium.
• Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
• The use of prescribed doses of potassium supplements.
• Illness requiring overnight hospitalization in the past 6 months
• Active tobacco or recreational drug use
• Pregnancy or current breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lisinopril	Lisinopril	Lisinopril - open-label, 2.5-40mg daily

Primary Outcome Measures

Name	Time	Method
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration	1 week	PTH values 1 week following ACE inhibitor therapy

Secondary Outcome Measures

Name	Time	Method
Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy	1 week
Serum Calcium Following 1 Week of ACE Inhibitor Administration	1 week

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States